End Result

FDA regulations create an impenetrable shield behind which the FDA and drug companies hold their discussions. The FDA cannot correct misinformation or offer their perspective on problems in clinical trials to anyone without the drug company's permission. Examples:

While FDA can halt a clinical trial for safety reasons, the agency cannot communicate directly with the patients in the trial.

When FDA invites public comment at open meetings, briefing information for the meeting is not publicly available until 24 hours prior to the meeting. This makes it difficult for the public to provide informed comment.

Our Goal

We challenge both Congress and the FDA to permit public disclosure at critical times in drug development for deadly diseases. When the FDA turns a drug down or stops a trial for a life-threatening disease, the public's right to know must take priority over the protection of proprietary or commercial interests.